Generalized Anxiety DisorderSkillJoyNCT05040061
SkillJoy Clinical Trial
A study testing SkillJoy Intervention in people with Generalized Anxiety Disorder, run by Skidmore College at 1 site in United States.
Trial summary
This study is a randomized controlled trial comparing a smartphone-delivered savoring intervention (SkillJoy) for Generalized Anxiety Disorder to an active treatment control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- SkillJoy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2018to 7 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet clinical criteria for Generalized Anxiety Disorder on the GAD-Q-IV and the GAD section of the Mini-International Neuropsychiatric Interview (MINI).
- Must be at least 18 years old to participate.
- Pregnant women will be allowed to participate.
Who cannot join
- They do not meet criteria for GAD on the GAD-Q-IV and the INI or do not fall one standard deviation below the subject pool mean on the GAD-Q-IV (i.e., they fall between these two scores).
- They are younger than 18 years of age.
- They do not speak English.
- They are adults unable to consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SkillJoy Randomized Controlled Trial: Testing a Smartphone Intervention for Anxiety and Reinforcement
This study is a randomized controlled trial comparing a smartphone-delivered savoring intervention (SkillJoy) for Generalized Anxiety Disorder to an active treatment control.
Read the detailed description
The current study seeks to determine if the positivity intervention SkillJoy, a smartphone-based, ecological momentary intervention (EMI), can reduce worry and generalized anxiety disorder (GAD) symptoms, increase positive emotion and wellbeing, improve reinforcement and probabilistic learning, increase savoring and reduce kill-joy thinking, and decrease avoidance of negative emotional shifts relative to an active treatment control in a GAD sample. Skills for generating positive emotion may reduce symptoms and increase well-being for those with GAD. To test this approach, participants with GAD were randomly assigned to either a savoring treatment or a self-monitoring control.The savoring treatment consisted of an ecological momentary intervention (EMI) for learning and practicing savoring skills-SkillJoy. SkillJoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events. The active self-monitoring control EMI consisted of similar activities, but they all omitted savoring practices. These activities included attending to any current thoughts and feelings, planning everyday activities, remembering and recording daily events, and anticipating important events. Both EMIs were delivered by apps on participants' smartphones for seven days with 30th day follow-up. Secondarily, the current study will assess differences between those with GAD and non-anxious controls on a computerized probabilistic reinforcement learning task and baseline savoring questionnaires.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- SkillJoy Intervention, Active Self-Monitoring Control Intervention
- Keywords
- Worry, Savoring, Ecological Momentary Intervention, Generalized Anxiety Disorder, Positive Emotion
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkillJoy InterventionBehavioural
The savoring treatment consisted of an ecological momentary intervention (EMI) for learning and practicing savoring skills-SkillJoy. SkillJoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events.
Active Self-Monitoring Control InterventionBehavioural
The active self-monitoring control EMI prompted participants to notice and write current thoughts and feelings, plan the day's major activities, remember and write about their daily events, and anticipate upcoming important events.
| Study group | Role | What they receive |
|---|---|---|
| SkillJoy Intervention | Experimental | The savoring treatment consisted of an ecological momentary intervention (EMI) for learning and practicing savoring skills-SkillJoy. SkillJoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events. Receives: Behavioral: SkillJoy Intervention |
| Active Self-Monitoring Control Intervention | Active comparator | The active self-monitoring control EMI consisted of similar activities, but they all omitted savoring practices. These activities included attending to any current thoughts and feelings, planning everyday activities, remembering and recording daily events, and anticipating important events. Receives: Behavioral: Active Self-Monitoring Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Penn State Worry Questionnaire
A 16-item self-report scale of the severity and frequency of worry. Min. score of 16 and maximum score of 80. Decreases in scores suggest a better outcome.
Measured: 8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Positive and Negative Affect Schedule, Expanded Form: Joviality Scale
An 8-item measure of positive emotions. Min. score of 8 and maximum score of 40. Increases in scores suggest a better outcome.
Measured: 8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Savoring the Moment Subscale of the Savoring Beliefs Inventory
The SBI is a 14-item survey that measures beliefs about one's ability to savor. The savoring the moment subscale measures savoring of present-moment emotional experience. Min. score of 1 and maximum score of 7. Increases in scores suggest a better outcome.
Measured: 8 day post-trial; 30th day follow-up
Secondary outcomes (5)
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Responses to Positive Affect Scale: Dampening Subscale
Measure kill-joy thinking (a.k.a. "dampening"). Participants rated eight dampening items on a 5-point scale. Min. score of 8 and maximum score of 32. Decreases in scores suggest a better outcome.
Measured: 8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Prioritizing Positivity Scale
Measures the degree to which participants prioritized seeking positive experiences on six items with which participants either agree or disagree on a nine-point scale. Min. score of 6 and maximum score of 54. Increases in scores suggest a better outcome.
Measured: 8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Life Orientation Test - Revised
Measures optimism. It has 10 items rated on a four-point scale. Min. score of 6 and maximum score of 30. Increases in scores suggest a better outcome.
Measured: 8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Beck Depression Inventory II
A 21-item self-report survey that measures the presence and severity of depressive symptoms. Minimum score of 0 and maximum score of 63. Decreases in scores suggest a better outcome.
Measured: 8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Contrast Avoidance Questionnaire - Worry
Measures frequency, severity, and motivation to use worry to cope with negative shifts in emotion and benefit from positive shifts in emotion. Min. score of 30 and maximum score of 150. Decreases in scores suggest a better outcome.
Measured: 5 day mid-trial; 8 day post-trial; 30th day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start17 May 2018
- Primary completion7 Dec 2019
- Study completion7 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants screened to select-in GAD with a clinical interview are randomly assigned to either a savoring treatment intervention condition (SkillJoy) or an active treatment control condition emphasizing self-monitoring.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skidmore College
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040061
- Sponsor's protocol ID
- 2108-974
- Acronym
- SkillJoy
- Status last verified
- Sep 2021
- First submitted
- 24 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any relevant de-identified IPD will be shared to other researchers upon reasonable, direct request.
Publications
LaFreniere LS, Newman MG. Savoring changes novel positive mindset targets of GAD treatment: Optimism, prioritizing positivity, kill-joy thinking, and worry mediation. Behav Res Ther. 2024 Jun;177:104541. doi: 10.1016/j.brat.2024.104541. Epub 2024 Apr 16.
PubMed 38640622LaFreniere LS, Newman MG. Upregulating positive emotion in generalized anxiety disorder: A randomized controlled trial of the SkillJoy ecological momentary intervention. J Consult Clin Psychol. 2023 Jun;91(6):381-387. doi: 10.1037/ccp0000794. Epub 2023 Jan 30.
PubMed 36716146
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SkillJoy Randomized Controlled Trial: Testing a Smartphone Intervention for Anxiety and Reinforcement
- ClinicalTrials.gov ID
- NCT05040061
- Acronym / sponsor ID
- SkillJoy / 2108-974
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Worry, Savoring, Ecological Momentary Intervention, Generalized Anxiety Disorder, Positive Emotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Skidmore CollegeUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- 17 May 2018 (actual)
- Primary completion
- 7 Dec 2019 (actual)
- Study completion
- 7 Dec 2019 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial comparing a smartphone-delivered savoring intervention (SkillJoy) for Generalized Anxiety Disorder to an active treatment control.
Detailed description
The current study seeks to determine if the positivity intervention SkillJoy, a smartphone-based, ecological momentary intervention (EMI), can reduce worry and generalized anxiety disorder (GAD) symptoms, increase positive emotion and wellbeing, improve reinforcement and probabilistic learning, increase savoring and reduce kill-joy thinking, and decrease avoidance of negative emotional shifts relative to an active treatment control in a GAD sample. Skills for generating positive emotion may reduce symptoms and increase well-being for those with GAD. To test this approach, participants with GAD were randomly assigned to either a savoring treatment or a self-monitoring control.The savoring treatment consisted of an ecological momentary intervention (EMI) for learning and practicing savoring skills-SkillJoy. SkillJoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events. The active self-monitoring control EMI consisted of similar activities, but they all omitted savoring practices. These activities included attending to any current thoughts and feelings, planning everyday activities, remembering and recording daily events, and anticipating important events. Both EMIs were delivered by apps on participants' smartphones for seven days with 30th day follow-up. Secondarily, the current study will assess differences between those with GAD and non-anxious controls on a computerized probabilistic reinforcement learning task and baseline savoring questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants screened to select-in GAD with a clinical interview are randomly assigned to either a savoring treatment intervention condition (SkillJoy) or an active treatment control condition emphasizing self-monitoring.
| Arm | Type | Receives |
|---|---|---|
| SkillJoy Intervention | Experimental | Behavioral: SkillJoy InterventionThe savoring treatment consisted of an ecological momentary intervention (EMI) for learning and practicing savoring skills-SkillJoy. SkillJoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events. |
| Active Self-Monitoring Control Intervention | Active comparator | Behavioral: Active Self-Monitoring Control InterventionThe active self-monitoring control EMI consisted of similar activities, but they all omitted savoring practices. These activities included attending to any current thoughts and feelings, planning everyday activities, remembering and recording daily events, and anticipating important events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet clinical criteria for Generalized Anxiety Disorder on the GAD-Q-IV and the GAD section of the Mini-International Neuropsychiatric Interview (MINI).
- Must be at least 18 years old to participate.
- Pregnant women will be allowed to participate.
Key exclusion criteria (4 listed)
- They do not meet criteria for GAD on the GAD-Q-IV and the INI or do not fall one standard deviation below the subject pool mean on the GAD-Q-IV (i.e., they fall between these two scores).
- They are younger than 18 years of age.
- They do not speak English.
- They are adults unable to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SkillJoy InterventionThe savoring treatment consisted of an ecological momentary intervention (EMI) for learning and practicing savoring skills-SkillJoy. SkillJoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events. | Behavioural | SkillJoy Intervention |
| Active Self-Monitoring Control InterventionThe active self-monitoring control EMI prompted participants to notice and write current thoughts and feelings, plan the day's major activities, remember and write about their daily events, and anticipate upcoming important events. | Behavioural | Active Self-Monitoring Control Intervention |
Primary outcome
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Penn State Worry Questionnaire
Time frame: 8 day post-trial; 30th day follow-up
A 16-item self-report scale of the severity and frequency of worry. Min. score of 16 and maximum score of 80. Decreases in scores suggest a better outcome.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Positive and Negative Affect Schedule, Expanded Form: Joviality Scale
Time frame: 8 day post-trial; 30th day follow-up
An 8-item measure of positive emotions. Min. score of 8 and maximum score of 40. Increases in scores suggest a better outcome.
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Savoring the Moment Subscale of the Savoring Beliefs Inventory
Time frame: 8 day post-trial; 30th day follow-up
The SBI is a 14-item survey that measures beliefs about one's ability to savor. The savoring the moment subscale measures savoring of present-moment emotional experience. Min. score of 1 and maximum score of 7. Increases in scores suggest a better outcome.
5 secondary outcomes
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Responses to Positive Affect Scale: Dampening Subscale
Time frame: 8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Prioritizing Positivity Scale
Time frame: 8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Life Orientation Test - Revised
Time frame: 8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Beck Depression Inventory II
Time frame: 8 day post-trial; 30th day follow-up
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in Contrast Avoidance Questionnaire - Worry
Time frame: 5 day mid-trial; 8 day post-trial; 30th day follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Derived from this study: PubMed 38640622LaFreniere LS, Newman MG. Savoring changes novel positive mindset targets of GAD treatment: Optimism, prioritizing positivity, kill-joy thinking, and worry mediation. Behav Res Ther. 2024 Jun;177:104541. doi: 10.1016/j.brat.2024.104541. Epub 2024 Apr 16.
- Derived from this study: PubMed 36716146LaFreniere LS, Newman MG. Upregulating positive emotion in generalized anxiety disorder: A randomized controlled trial of the SkillJoy ecological momentary intervention. J Consult Clin Psychol. 2023 Jun;91(6):381-387. doi: 10.1037/ccp0000794. Epub 2023 Jan 30.
- Individual participant dataSharing planned: Yes. Any relevant de-identified IPD will be shared to other researchers upon reasonable, direct request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SkillJoy Intervention in people with Generalized Anxiety Disorder, run by Skidmore College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre- to Post-Trial and Pre-Trial to Follow-Up Change in The Penn State Worry Questionnaire (time frame: 8 day post-trial; 30th day follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040061, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.